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New therapies - safety first

The Environment Committee on Tuesday backed a draft EU regulation designed to encourage the development of gene therapy, cell therapy and tissue engineering.

However, MEPs are demanding guarantees about the safety of the products and techniques used and would also like to see more support for smaller companies working in this field. They rejected a number of ethical amendments which had prevented an earlier report being adopted in September. Gene therapy, cell therapy and tissue engineering hold out great promise for the treatment of cancer, Parkinson's disease and serious burns.
Parliament's Committee on the Environment and Public Health yesterday adopted a report, which approves, with a number of amendments, a proposal by the European Commission to introduce a single legislative framework with a centralized authorization procedure for these innovative therapies. The aim is encourage their development while guaranteeing patient safety and facilitating access by companies to the European market.

Ethical issues not covered by draft regulation
Last September an initial report was rejected because of a controversy between Members over the inclusion of several amendments calling for ethical safeguards which had not been included in the Commission's draft regulation; the latter refers to Member States' prerogatives regarding the sensitive issues of stem cells and human embryos, in the name of the subsidiarity principle.
Now, ending several months of lively debate on these matters, members of the Environment Committee have finally rejected the amendments stating that the regulation specifically rejects any commercialisation of the human body, of products that modify the human germ line (which contains each individual's own genetic material) as well as products derived from human-animal hybrids or chimeras (created by introducing cells of another species into an embryo). The committee simply adopted instead an amendment submitted by the Legal Affairs Committee calling for the scope of the regulation to exclude medicines containing or deriving from human embryonic and foetal cells or human germ cells.

Combined medicines produced by hospitals
In the case of a „combined advanced therapy medicinal product” (one which contains a medical device plus bio-material), such as heart pumps, artificial joints or artificial kidneys, the entire product should, say MEPs, be the subject of a final evaluation by the European Medicines Agency (EMEA). The agency could take account of other evaluations made by other bodies identified in conjunction with the applicant, in accordance with other directives.
MEPs also want to exclude from the regulation advanced therapy medicinal products prepared in full in a hospital „on a one-off basis according to a specific, non-standardized and non-patented process”. The committee also wishes to clarify certain definitions, such as those of products of tissue engineering (to exclude non-viable human or animal tissues) and combined medicinal products. The latter, says the committee, should be made of viable cells or tissue, or of components whose action can be considered as primary if they are not viable.

Strengthening risk management and European expertise
The Environment Committee is calling for the efficacy and any adverse reactions of products to be monitored. It wants the Commission to demand a system of risk management if there is any particular reason for concern. The aim should be to „identify, characterize, prevent or minimize risks” related to these products. MEPs also adopted several amendments seeking to strengthen the role, expertise and independence of the future Committee for Advanced Therapies, which will monitor scientific developments in this field and advise EMEA when the latter assesses applications to market new products.
All members of the Committee for Advanced Therapies should, say MEPs, have experience in the field of advanced therapies and at least two or more should have „scientific expertise” in medical devices. In addition, members and alternate members of the committee must „have no financial or other interests in the biotechnology sector and medical device sector” and any other indirect interests related to these sectors must be entered in a register.

More incentives for smaller companies
To boost the development of innovative therapies, the Commission has proposed reducing by 90% the fee payable to EMEA. Members of the Environment Committee, however, believe that this reduction of 90% should be granted only to smaller companies (SMEs) and that other firms should get a maximum reduction of 65%. They also want incentives for SMEs, a reduction of 50% in the marketing authorization fee they pay and technical support for such firms.

Transition period
Lastly, the Environment Committee believes that the two-year transition period proposed by the Commission for existing products to comply with regulation is too short. They suggest instead that products other than tissue engineered products should have a four-year transition period. (EP Press)